1275148SCD2001: Ustekinumab and Golimumab in Sarcoidosis
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis
IRAS ID
25236
Sponsor organisation
Centocor B.V.
Eudract number
2009-010714-30
ISRCTN Number
Unknown
Research summary
The study will assess the safety and effectiveness of ustekinumab or golimumab (administered as individual treatments in addition to current therapy) compared to placebo (dummy treatment) in subjects with chronic sarcoidosis with lung and/or skin involvement who remain symptomatic despite their current therapy. Adult male and female subjects = 18 to = 85 years of age will be screened for eligibility. Subjects eligible for this study must have proven sarcoidosis which began at least 2 years prior to screening. A total of approximately 180 subjects will be enrolled into this study.Following screening (Weeks -1 to -4), subjects will be randomised to receive one of the 3 study treatments. A loading dose (a higher dose to commence therapy) of ustekinumab, golimumab or placebo will be administered at Week 0, followed by further administrations at Weeks 4, 8, 12, 16, 20, and 24. The primary endpoint will be assessed at Week 16. Subjects will be followed through to Week 44.All subjects participating in the study will have blood samples drawn at specified timepoints for measurement of ustekinumab or golimumab concentrations in the blood and to check for the existence of antibodies to ustekinumab or golimumab. For consenting subjects, samples for pharmacogenetic (PG) (DNA) analysis, skin photographs, and skin biopsy samples will also be collected.In total, approximately 40 sites globally will participate.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
09/H0206/39
Date of REC Opinion
14 Sep 2009
REC opinion
Further Information Favourable Opinion